Runxin Pharmaceutical Grade Chondroitin Sulfate | cGMP Certified Source Factory

Manufacturer Profile: Runxin – Pharmaceutical Excellence Since 1998
Runxin stands as a globally recognized manufacturer with over 28 years of specialized expertise in producing premium pharmaceutical-grade chondroitin sulfate and sodium hyaluronate. Our advanced manufacturing facilities maintain comprehensive international certifications including cGMP, ISO9001, ISO22000, ISO13485, HACCP, HALAL, and FSSC22000, with particular emphasis on our pharmaceutical-grade manufacturing standards. Serving pharmaceutical companies and healthcare manufacturers across 70+ countries, we combine state-of-the-art purification technologies with rigorous pharmaceutical quality systems to deliver active pharmaceutical ingredients (APIs) of exceptional purity, safety, and efficacy.

Product Overview: Pharmaceutical Grade Chondroitin Sulfate
Runxin's Pharmaceutical Grade Chondroitin Sulfate is manufactured under strict cGMP conditions specifically for pharmaceutical applications and medical use. Available in high-purity specifications (95%, 98%, 99% purity), our product undergoes comprehensive quality verification including identity testing, purity analysis, and biological activity assessment. The manufacturing process incorporates pharmaceutical-grade purification methods including chromatography, ultrafiltration, and crystallization to ensure compliance with international pharmacopeia standards including USP, EP, and JP.

Key Advantages

• Pharmacopeia Compliance: Meets USP, EP, and JP standards for pharmaceutical applications

• Validated Manufacturing: Fully validated processes under cGMP conditions

• Batch Traceability: Complete documentation and traceability for every production batch

• Enhanced Bioavailability: Optimized molecular characteristics for therapeutic efficacy

• Global Regulatory Support: Documentation suitable for international drug registrations

Technical Specifications

• Appearance: White to light yellow powder

• Purity: 90%, 95% (HPLC)

• Loss on Drying: ≤10%

• Protein Content: ≤6%

• pH (1% solution): 5.5-7.5

• Electrophoretic purity：Not more than 2 of any individual impurity is found

• Specific rotation：-20.0º ～ -30.0º

• Chloride：≤ 0.50%

• Sulfate：≤ 0.24%

• Microbiological Profile:

• Total Plate Count: <1000 CFU/g

• Yeast & Mold: <100 CFU/g

• E. coli: Negative

• Salmonella: Negative

• Certifications: cGMP, ISO9001, ISO22000, ISO13485, HACCP, HALAL, FSSC22000

Applications

• Prescription pharmaceuticals for osteoarthritis treatment

• Over-the-counter joint health medications

• Medical device coatings and formulations

• Veterinary pharmaceuticals

• Clinical nutrition products

• Advanced drug delivery systems

FAQs About Pharmaceutical-Grade Chondroitin Sulfate

1. What distinguishes pharmaceutical-grade chondroitin sulfate from other grades?
   Pharmaceutical-grade chondroitin sulfate undergoes additional purification steps, meets strict pharmacopeia standards (USP/EP/JP), includes endotoxin testing, and requires full manufacturing documentation and batch traceability suitable for drug applications.

2. How does your cGMP certification ensure pharmaceutical quality standards?
   Our cGMP certification, supported by ISO9001, ISO22000, ISO13485, HACCP, HALAL, and FSSC22000 standards, ensures rigorous quality control, validated manufacturing processes, complete documentation, and continuous quality verification throughout production, meeting international pharmaceutical regulatory requirements.

3. What documentation package do you provide for drug regulatory submissions?
   We provide comprehensive regulatory support including Drug Master Files (DMF), Certificate of Analysis, manufacturing process validation, stability studies, and all necessary certification documents to support FDA, EMA, and other international drug regulatory submissions.

4. Can you supply chondroitin sulfate with specific pharmacopeia compliance?
   Yes, we can manufacture chondroitin sulfate compliant with USP, European Pharmacopoeia, or Japanese Pharmacopoeia standards, with appropriate testing and documentation for each specific pharmacopeia requirement.

5. What is the typical lead time for pharmaceutical-grade orders?
   Standard lead time is 4-6 weeks, with expedited options available. All batches undergo comprehensive quality testing and documentation preparation before release, ensuring compliance with pharmaceutical industry requirements.

Why Choose Runxin as Your Pharmaceutical Partner

• 28+ Years of Pharmaceutical Experience: Extensive expertise in API manufacturing since 1998

• Comprehensive Pharmaceutical Certifications: Full compliance with cGMP, ISO9001, ISO22000, ISO13485, HACCP, HALAL, and FSSC22000

• Global Regulatory Experience: Successful track record with international drug authorities

• Quality Assurance: Rigorous testing and documentation for pharmaceutical applications

• Technical Partnership: Comprehensive support from development to commercial manufacturing

Partner with a Trusted Pharmaceutical Ingredient Leader
Choose Runxin for your pharmaceutical-grade chondroitin sulfate requirements and leverage our 28 years of manufacturing excellence in the pharmaceutical industry. Contact us today to request samples, obtain certification documents, or discuss your specific pharmaceutical application needs. Let our expertise in pharmaceutical ingredients and regulatory compliance support your success in developing and manufacturing effective pharmaceutical products for global markets.